16 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
DANEK SACRAL HOOK
FDA 510(k)
FDA Class 2
·Orthopedic
Map-iT
FDA UDI
ACCESS POINT TECHNOLOGIES, INC.·00818083014896·Fixed, 10 electrode, MPB, 4-4-4-23-4-4-4-4-4mm ...
Printed Lower Crown Pack for Herbst LR4 8mm
FDA UDI
SPECIALTY APPLIANCES, LLC·D8199015900·
ERA 2.2MM IMP 0DEG MICRO HEAD 15X3MM, Ti
FDA UDI
STERNGOLD DENTAL LLC·00841549108594·Designed for both transitional and long-term de...
Sklar®
FDA UDI
SKLAR CORPORATION·10649111277542·MAYO DISS SCISS STR 9"
DND 101
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
DIGITAL FLAT PANEL X-RAY DETECTOR
FDA 510(k)
FDA Class 2
·Radiology
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 3 L
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·December 23, 2020
HAWKINS II
FDA Adverse Event
Injury
·ARGON MEDICAL DEVICES·Product code GDM·May 12, 2014
SIZE 6 ACCOLADE II 127 DEG
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS CORK·Product code MEH·January 3, 2013
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·November 12, 2010
REDUCED SIZE SCREW EXPANDABLE LEFT DISTAL FEMORAL 20CM REPLACEMENT
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code JWH·March 26, 2021
Affixus¿ Hip Fracture Nail Left 130¿ 11 mm x 380 mm, Item Number: 814611380
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 19, 2018
Medtronic Sofamor Danek USA, CD Horizon Spinal System Agile Dynamic Stabilization Device, REF 7901590, 15mm, 5.5mm dia x 90mm, size: 15mm x 90mm, for spinal fixation.
FDA Recall
Terminated
·Medtronic Sofamor Danek USA Inc·Product code NQP·November 12, 2007
Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012
TRULIANT Knee System including TRULIANT Tibial Inserts, also labeled as the following: a. TRULIANT CR Tibial Inserts; b. TRULIANT CR Slope + Tibial Inserts; c. TRULIANT CR Slope ++ Tibial Inserts; d. TRULIANT CRC Tibial Inserts; e. TRULIANT PS Tibial Inserts; f. TRULIANT PSC Tibial Inserts. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021